e. Monitoring.
6. A practical training designed to assess the competency of the delegate prior to starting the validation process. The practical training shall include simulation of at least two occurrences of each of the following:
a. Wrong drug.
b. Wrong strength.
c. Wrong formulation.
d. Omitted medication, if utilizing unit dose or compliance packaging.
(d) Completed the following validation process:
1. The delegate being validated shall make a product verification on the work of a pharmacist or unlicensed person for accuracy and correctness of a minimum of 500 product verifications over a minimum of 5 separate days and achieve an accuracy rate of at least 99.8%.
2. A pharmacist shall audit 100% of the product verifications made by the delegate during the validation process.
(e) Notwithstanding, par (a) to (d), a delegate who completed the pilot program validation process between October 1, 2016 and September 30, 2019 meets the delegation qualifications unless the delegate fails to meet the quality assurance standards under sub. (4)
(3) Eligible product. (a) Institutional pharmacies. The delegate may do the product verification in an institutional pharmacy if the product meets all of the following:
1. Is in an original package from a manufacturer or if the licensed pharmacist has ensured that any repackaging of stock results in a package that is labeled with the correct drug name, strength, formulation, control or lot number, and beyond use date.
2. Has a drug utilization review performed by a pharmacist prior to dispensing.
3. Will be administered by an individual authorized to administer medications at the institution where the medication is administered.
(b) Community pharmacies. The delegate may do the product verification in a community pharmacy if the medications meets all of the following:
1. Is in an original package from a manufacturer or if the licensed pharmacist has ensured that any repackaging of stock results in a package that is labeled with the correct drug name, strength, formulation, control or lot number, and beyond use date.
2. Has a drug utilization review performed by a pharmacist prior to dispensing.
3. Includes a description of the medication on the prescription label that allows for a non pharmacist to check the accuracy of the medication after it is delivered.
(4) Quality assurance. (a) A minimum of 5% of each delegate’s product verifications shall be audited by a licensed pharmacist. The accuracy of each delegate shall be tracked individually.
(b) A record of each delegate-check-delegate audit shall include all of the following:
1. Name of the product verification delegate.
2. Total number of product verifications performed.
3. Number of product verifications audited by the pharmacist.
4. Percentage of product verifications audited by pharmacist.
5. Percentage of accuracy.
6. Number of product verification errors identified.
7. Type of error under sub. (2) (c) 2.
(c) On a quarterly basis, the supervising pharmacist shall perform an assessment of each delegate’s previous 12 months accuracy and correctness of delegate-check-delegate product verifications including a review of the quality assurance log.
(d) A delegate shall be revalidated if the delegate fails to maintain a product verification accuracy rate of 99.8% based on the quarterly assessment of the previous 12 months or has not performed delegate-check-delegate product verifications within the last 6 months.
(5) Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the delegate-check-delegate which shall be made available to the board upon request.
(6) Records. (a) Each pharmacy shall maintain for 5 years the following records:
1. All validation records of each delegate that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.
2. Documentation indicating accepting responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising delegate-check-delegate pharmacist, indicating the name of the supervising delegate-check-delegate pharmacist, and the dates the supervision responsibilities begin and end.
3. Quality assurance audits and quarterly assessments.
(b) Records shall be made available to the board upon request.
Section 2. EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats. ---------------------------------------------------------------------------------------------------------------------
(END OF TEXT OF RULE)
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Dated October 23, 2019 Agency 
Chair of the Pharmacy Examining Board
